Trial Outcomes & Findings for A Comparison of the Effects of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement (NCT NCT00756236)

Last Updated: 2017-07-31

Results Overview

We will measure the amount of Sevoflurane used to achieve the same level Bispectral Index. Each patient will have their percentage of sevoflurane in expired breath measured every 5 minutes for 2 hours, resulting in 24 data points per person. The primary endpoint will be area under the curve (AUC) for each subject for the first hour.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Every 5 minutes for 2 hours

Results posted on

2017-07-31

Participant Flow

Subjects were consented at the pre-surgical clinical visit if they were outpatients. Inpatients were consented while they were in the hospital. Each patient were provided with a copy of the informed consent and be given at least 12 hours to make a decision.

Group assignments were randomized by a pharmacist who also prepared the study drugs. Investigators and subjects were blinded to the group assignment.

Participant milestones

Participant milestones
Measure	M-Group Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment. Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration	E-Group Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment. Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl	P-Group Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml \& 5ml syringes. P-Group: 0.9%NaCl dispensed in 60ml \& 5ml syringes
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of the Effects of Intraoperative Administration of Metoprolol or Esmolol on General Anesthetic Requirement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	M-Group n=20 Participants Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment. Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration	E-Group n=20 Participants Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment. Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl	P-Group n=20 Participants Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml \& 5ml syringes. P-Group: 0.9%NaCl dispensed in 60ml \& 5ml syringes	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	55 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Age, Continuous	44 YEARS STANDARD_DEVIATION 13.3 • n=5 Participants	49 YEARS STANDARD_DEVIATION 11.8 • n=7 Participants	48 YEARS STANDARD_DEVIATION 15.2 • n=5 Participants	46.8 YEARS STANDARD_DEVIATION 13.2 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	17 Participants n=7 Participants	14 Participants n=5 Participants	43 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: Every 5 minutes for 2 hours

Outcome measures

Outcome measures
Measure	M-Group n=20 Participants Patients were randomly assigned to Metoprolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 1mg/ml Metoprolol. Investigators and patients were blinded to the group assignment. Metoprolol: 60ml syringes of 0.9% NaCl, 5ml syringes of metoprolol at 1mg/ml concentration	E-Group n=20 Participants Patients were randomly assigned to Esmolol Group. The drug was dispensed in 60ml \& 5ml syringes of 0.9% NaCl and 10mg/ml Esmolol. Investigators and patients were blinded to the group assignment. Esmolol: 60ml syringes of esmolol at 10 mg/ml concentration, 5ml syringes of 0.9% of NaCl	P-Group n=19 Participants Patients were randomly assigned to this group. Patients received 0.9% NaCl only. To maintain the blind, 0.9% NaCl was also dispensed in 60ml \& 5ml syringes. P-Group: 0.9%NaCl dispensed in 60ml \& 5ml syringes
Area Under the Curve of etSEV Over the First Hour	1.77 percent*hour Standard Deviation 0.38	1.46 percent*hour Standard Deviation 0.29	1.73 percent*hour Standard Deviation 0.47

Adverse Events

M-Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

E-Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

P-Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mehmet Ozcan, MD

Department of Anesthesia. OUHSC

Phone: 405-271-4351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place